Xiaflex Kit
NDC Package 66887-003-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Xiaflex (collagenase clostridium histolyticum) kits is a medication used to treat certain conditions (Dupuytren's contracture, Peyronie's disease) that are caused by a certain protein (collagen) in your body. This formulation utilizes a kit delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 66887-003 and is authorized under FDA application BLA125338.

Identification & Billing

NDC Package Code
66887-003-01
Package Description
1 KIT in 1 CARTON * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 3 mL in 1 VIAL
Product Code
66887-003
11-Digit Billing Format
66887000301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xiaflex
Non-Proprietary Name
Collagenase Clostridium Histolyticum
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to treat certain conditions (Dupuytren's contracture, Peyronie's disease) that are caused by a certain protein (collagen) in your body. Collagen is a tough and strong substance and is found in the knots/cords of the hand in Dupuytren's contracture or plaques in the penis in Peyronie's disease. Collagenase is a substance (enzyme) that breaks down the collagen in these knots/cords/plaques.

Regulatory & Marketing

Labeler Name
Endo Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125338
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-22-2010
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (66887-003). Click a package code to view its specific billing and regulatory data.

66887-003-02
2 CARTON in 1 CARTON / 1 KIT in 1 CARTON * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 3 mL in 1 VIAL

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66887-003-01 identifies a specific commercial package of 1 kit in 1 carton * 1 injection, powder, lyophilized, for solution in 1 vial * 3 ml in 1 vial of Xiaflex, a human prescription drug labeled by Endo Usa, Inc.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Endo Usa, Inc. on February 22, 2010. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat certain conditions (Dupuytren's contracture, Peyronie's disease) that are caused by a certain protein (collagen) in your body. Collagen is a tough and strong substance and is found in the knots/cords of the hand in Dupuytren's contracture or plaques in the penis in Peyronie's disease. Collagenase is a substance (enzyme) that breaks down the collagen in these knots/cords/plaques.

How is this Endo Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66887000301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
66887-003-01
11-Digit CMS (5-4-2)
66887-0003-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.